[Federal Register: October 24, 2007 (Volume 72, Number 205)]
[Page 60377-60378]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2007P-0047]

Nonprescription Drugs Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Nonprescription Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on December 14, 2007, from 
8 a.m. to 5 p.m.
    Addresses: Electronic comments should be submitted to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Select ``2007P-0047--Amend the Dosage of 

Oral Phenylephrine Listed in the Final Monograph on Oral 
Decongestants,'' and follow the prompts to submit your statement. 
Written comments should be submitted to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852, by close of business on December 30, 
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 
Colesville Rd., Silver Spring, MD. The hotel telephone number is 301-
    Contact Person; Diem-Kieu Ngo, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for 
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 
301-827-7001, FAX: 301-827-6776, e-mail: Diem.Ngo@fda.hhs.gov, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301) 443-0572 in 
the Washington, DC area), code 3014512541. Please call the Information 
Line for up-to-date information on this meeting. A notice in the 
Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the agency's Web site and call the appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: The committee will discuss the safety and effectiveness of 
phenylephrine hydrochloride and phenylephrine bitartrate as over-the-
counter (OTC) oral nasal decongestants. The discussion at the meeting 
will address a citizen petition submitted to FDA on February 1, 2007 
(Docket No. 2007P-0047/CP1), which asserts that the available data do 
not support the adult and pediatric doses of phenylephrine 
hydrochloride and phenylephrine bitartrate that are generally 
recognized as safe and effective in the OTC drug monograph for Cold, 
Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products 
(CCABADP) in 21 CFR part 341. The meeting will focus on the review of 
existing safety and efficacy data and the petitioner's request that the 
CCABADP monograph be amended to increase the adult dose of 
phenylephrine hydrochloride from 10 to 25 milligrams (mg) and that of 
phenylephrine bitartrate from 15.6 to 40 mg.
    Additional information was submitted to the docket for OTC Nasal 
Decongestants (Docket No. 1976N-0052N; submissions EMC140, C251, C253 
and Supplement 13) and is related to the petition or the petitioner's 
publications. These submissions were submitted to the OTC Nasal 
Decongestant docket and have been cross-referenced and linked to Docket 
No. 2007P-0047. The petition and other relevant submissions can be 
found at the following Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/dockets/07p0047/07p0047.htm

    Other information in Docket No. 1976N-0052N may be considered. For 
example, see comments 10 and 11 of the Tentative Final Monograph for 
OTC Nasal Decongestants, published in the Federal Register of January 
15, 1985 (50 FR 2220 at 2226).
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material will be 
available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 

the year 2007 and scroll down to the appropriate advisory committee 
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
November 30, 2007. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Those desiring to make formal 
oral presentations should notify the contact person and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their presentation 
on or before November 22, 2007. Time allotted for each presentation may 
be limited. If the number of registrants

[[Page 60378]]

requesting to speak is greater than can be reasonably accommodated 
during the scheduled open public hearing session, FDA may conduct a 
lottery to determine the speakers for the scheduled open public hearing 
session. The contact person will notify interested persons regarding 
their request to speak by November 23, 2007.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Diem-Kieu Ngo at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.htm
 for procedures on public conduct during advisory committee 

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 18, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. 07-5249 Filed 10-23-07; 8:45 am]